The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acesulfame potassium (ACK) as a generalpurpose sweetener and flavor enhancer in food, not including meat and poultry. This action
[[Page 75412]]
is in response to a food additive petition filed by Nutrinova, Inc. It will simplify the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for overthecounter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2004. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Biological Response Modifiers Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Department of Health and Human Services of the United States of America and Swissmedic of the Swiss Confederation. The purpose of this MOU is to further enhance and strengthen communication and existing public

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration (FDA), Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada. The purpose of this MOU is to enhance and strengthen the exchange of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a call for data for certain categories of ingredients in overthecounter (OTC) drug products that are eligible for the original OTC drug review but have not been reviewed by FDA to date. FDA will review the submitted data and information as part of its ongoing review of OTC drug products to

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is providing notice of an exchange of letters between FDA and the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA). The participants concluded this exchange of letters on September 12, 2003. These letters express the intentions of FDA, the European Commission, and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore forming microorganisms. FDA is amending the regulations due to advances in facility, system, and equipment design and in sterilization technologies that

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with sporeforming microorganisms. FDA is proposing this amendment due to advances in facility, system, and equipment design and in sterilization

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This draft guidance provides recommendations for sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for generic

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing, as required by the Federal Advisory Committee Act, that the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2003.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committees: Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee.

General Function of the Committee: To provide

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Advisory Committee on Special Studies Relating to the Possible LongTerm Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee).

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Premarket Notification [510(k)] Submissions for Chemical Indicators.'' The document provides guidance for industry and other interested parties regarding the submission of chemical indicators such as process indicators, chemical integrators, and air

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) Sec. 110.300 entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's staff on enforcement of section 305 of the Public

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the veterinary prescription use of flunixin meglumine injectable solution for the control of inflammation in horses, beef cattle, and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of FDA's Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Human Dura Mater.'' This guidance document describes a means
[[Page 70514]]
by which human dura mater may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a guidance document related to food security entitled ``Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance'' (food security guidance) and a guidance document related to cosmetics security entitled ``Cosmetics Processors and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Prior Notice of Imported Food, Questions and Answers.'' The guidance responds to various questions raised about the section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration